POSLUMA Solution for injection Ref.[109999] Active ingredients: Flotufolastat ¹⁸F

2.1 Radiation Safety – Drug Handling

Handle POSLUMA with safety measures to minimize radiation exposure [see Warnings and Precautions (5.2)]. Use waterproof gloves, effective radiation shielding, including syringe shields, and other appropriate safety measures when handling and administering POSLUMA.

Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

Recommended Dose:

The recommended amount of radioactivity to be administered in adults is 296 MBq (8 mCi) as an intravenous bolus injection.

Preparation and Administration Instructions:

• Inspect POSLUMA visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored.
• Use aseptic technique and radiation shielding when withdrawing and administering POSLUMA.
• Calculate the necessary volume to administer based on calibration time and required dose.
• The recommended maximum volume of undiluted POSLUMA is 5 mL.
• POSLUMA may be diluted with 0.9% Sodium Chloride Injection, USP.
• Assay the dose in a dose calibrator before administration.

Post Administration Instructions:

• After the POSLUMA injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection, USP to ensure full delivery of the dose.
• Dispose of any unused drug in a safe manner in compliance with applicable regulations.

2.3 Patient Preparation

Instruct patients to drink water prior to administration of POSLUMA to ensure adequate hydration and to continue drinking and voiding frequently for the first few hours following administration to reduce radiation exposure.

2.4 Image Acquisition

• Patients should void immediately prior to imaging.
• Position the patient supine with arms above the head.
• Begin image acquisition approximately 60 minutes after POSLUMA injection.
• Image acquisition should start from mid-thigh and proceed to the base of the skull.
• Scan duration is approximately 20 minutes depending on the number of bed positions and acquisition time per bed position (typically 3 minutes). Adapt imaging technique according to the equipment used and patient characteristics in order to obtain the best image quality possible.

2.5 Image Display and Interpretation

POSLUMA binds to PSMA. PET images obtained using POSLUMA indicate the presence of PSMA in tissues [see Clinical Pharmacology (12.1)] . Lesions should be considered suspicious if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake is expected. Tumors that do not express PSMA will not be visualized. Increased uptake in tumors is not specific for prostate cancer [see Warnings and Precautions (5.1)].

2.6 Radiation Dosimetry

Estimated absorbed radiation doses for adult patients following intravenous injection of POSLUMA are shown in Table 1. The effective radiation dose resulting from the administration of the recommended activity of 296 MBq of POSLUMA is 4.1 mSv. The radiation absorbed doses to the critical organs of adrenal glands, kidneys, and submandibular glands for the recommended activity of 296 MBq are 54.3 mGy, 51 mGy, and 43.8 mGy, respectively. When PET/CT is performed, exposure to radiation will increase by an amount dependent on the settings used in the CT acquisition.

Table 1. Estimated Radiation Absorbed Doses in Organs/Tissues in Adults who Received POSLUMA:

^* The absorbed dose value reflects self-irradiation only; no dose contribution from other regions to the glands is added.
^** A 1-hour bladder voiding interval is assumed.

In the event of an overdose of POSLUMA, maintain hydration of the patient and frequent voiding to minimize radiation exposure. A diuretic might also be considered. If possible, an estimate of the radiation effective dose administered to the patient should be made.

Store POSLUMA at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Store POSLUMA in the original container in radiation shielding. The expiration date and time are provided on the container label. Use POSLUMA within 10 hours from end of synthesis.

Dispose of unused POSLUMA in compliance with applicable regulations.

This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.